A Comparison of Fidaxomicin and Oral Vancomycin for the Treatment of Clostridium Difficile Infection (CDI) in Hospitalized Patients Receiving Concomitant Antibiotics for the Treatment of Concurrent Systemic Infections
Fidaxomicin
+ Vancomycin
Infecciones por Clostridium+5
+ Diarrea
+ Infecciones Bacterianas y Micosis
Estudio de Tratamiento
Resumen
Fecha de inicio: 1 de mayo de 2017
Fecha en la que se inscribió al primer participante.Administration of concomitant antibiotics (CA) is a known risk factor for treatment failure in the treatment of CDI, as well as for recurrence of CDI. Recent data suggested that among patients receiving CA, fidaxomicin is superior to vancomycin. While these data are encouraging, many clinicians remain unclear on how to apply these data to patient care. Additionally, patients were excluded from the trials presented to the FDA if it was expected that they would require ≥ 7 days of CA. Therefore, the clinical question still remains of how to apply these data to the real world patient who requires a long course of CA and develops CDI while on therapy. We therefore propose an open label, comparative and prospective study of fidaxomicin 200 mg twice daily vs oral vancomycin 125 mg four times daily for the treatment of CDI among patients who are receiving a long course of CA. We hypothesize that fidaxomicin will be superior to vancomycin with respect to clinical cure for patients with CDI.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 144 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Estudio de Tratamiento
Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Cualquier sexo
Sexo biológico de los participantes elegibles para inscribirse.A partir de 18 años
Rango de edades de los participantes que pueden unirse al estudio.Voluntarios sanos no permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Condiciones
Patología
Criterios
Inclusion Criteria: * Patients 18 years of age or older with \>3 unformed stools/24 hours with positive stool test for C. difficile. * Patients receiving ≥ 1 high or medium risk antibiotic for treatment of an infection other than CDI, for an anticipated duration of ≥ 5 days from the time of enrollment. * High risk: carbapenems, 2nd-4th generation cephalosporins, fluoroquinolones, clindamycin, and beta-lactam/beta-lactamase inhibitor combinations * Medium risk: 1st generation cephalosporin, macrolides\*, and aztreonam * \*The macrolide would be considered to be low risk if patients are receiving intermittent macrolides for prophylaxis only and not for treatment of an acute infection Exclusion Criteria: * Patients with severe-complicated disease that would compromise oral therapy (hypotenstion or shock, ileus or bowel obstruction, megacolon). * Patients with an allergy to oral vancomycin or fidaxomicin. * Patients anticipated to receive metronidazole after enrollment. * Patients who already received oral vancomycin or metronidazole (either oral or intravenous) for \> 24 hours within the preceding 72 hours at the time of enrollment. * Patients anticipated to receive adjunctive C. difficile therapy (rifaxamin, nitazoxanide, tigecycline) after enrollment. * Patients who are on laxatives before they are enrolled into the study, such as lactulose, if: * Patients have had a recent dose adjustment; * Baseline number of bowel movement while on laxatives is unknown. * Number of bowel movements and/or consistency has not changed from baseline. * Patients who have had colostomy or ileostomy * Patients who will have colostomy or ileostomy after enrollment and before study ends * Patients who are or will be on long-term (\>12 weeks) medium or high-risk antibiotics prophylaxis after enrollment
Plan de Estudio
Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.2 grupos de intervención están designados en este estudio
0% de probabilidad de ser asignado al grupo placebo
Grupos de Tratamiento
Grupo I
Comparador ActivoGrupo II
Comparador ActivoObjetivos del Estudio
Objetivos Primarios
Objetivos Secundarios
Centros del Estudio
Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.Este estudio tiene 2 ubicaciones
St. Joseph Mercy Hospital
Ypsilanti, United States